Hyoscine Butylbromide Effect on Duration of Labor

Hyoscine Butylbromide Effect on Duration of Labor in Nulliparous Women: A Randomized, Double Blind, Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03441217

Enrollment

218

Registered

2018-02-22

Start date

2019-07-12

Completion date

2019-11-30

Last updated

2019-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor

Keywords

Duration of labor, Hyoscine butylbromide

Brief summary

To evaluate the duration of labour (active phase of labour) in nulliparous women with gestations between 37 and 41 6/7 weeks when 20 mg of Hyoscine butylbromide was applied intravenously and compared with similar patients that received a placebo.

Interventions

DRUGHyoscine Butylbromide 20Mg/1mL Injection

Nulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide upon arrival in the Labor and Delivery Unit (4-5 cms).

DRUGSaline Solution

Nulliparous women with gestations at term receive 20 mg of saline solution upon arrival in the Labor and Delivery Unit (4-5 cms).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* Low risk gestation between 37 and 41 6/7 weeks. * Cephalic (vertex) presentation. * Spontaneous labor in active phase (4 cms)

Exclusion criteria

* Premature rupture of membranes upon arrival at the Labor and Delivery Unit \> 4 hours. * Multiple order pregnancy. * Stillbirth. * Any fetal condition that could interfere in the mode of delivery (macrosomia, fetal growth restriction, oligohydramnios).

Design outcomes

Primary

Measure	Time frame	Description
Duration of first stage of labor	24 hours	Time measured from the moment the patient receive the allocated medication/placebo to complete dilation
Rate of cervical dilation	24 hours	Speed of cervical dilation (cms/hour) from the moment the patient receive the allocated medication/placebo to complete dilation

Secondary

Measure	Time frame	Description
Duration of labor	24 hours	Time measured from the moment the patient receive the allocated medication/placebo to delivery
Fetal and neonatal complications	72 hours	Number of adverse events (fetal or neonatal)

Countries

Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026